GMP Documentation: tailored to your Needs

No "GMP certificate" without GMP-compliant documentation

GMP (Good Manufacturing Practice) is often translated figuratively as "Give more paper”. In fact GMP compliant documentation is very extensive and covers the entire pharmaceutical quality management system. The GMP documents include instructional documents that describe and specify how something is done in a GMP-compliant manner, and reporting documents that prove that work has been done in a GMP-compliant manner. 

Do you want to check your documentation system for GMP compliance or set up a new GMP-compliant system?

Then we are the right partner for you! We are a GMP service provider with many years of experience and support you in manifold ways. In addition to our experienced GMP consultants, Valicare has a large number of documentation experts who know the gmp documentation requirements.. Thus, we can support you professionally and efficiently in the preparation of GMP compliant documents.

• We check the completeness of your GMP documents trough a gap analysis. The results are summarized in a report listing the measures required to bring your documentation system into the best and current level of GMP compliance. We can also support you in implementing these measures: in an accompanying consulting or by providing documentation support.
• We support you in setting up your pharmaceutical quality management system (PQS). In cooperation with you, we set up a system that meets your needs in terms of scope and complexity. We can also take over the entire documentation service.

Do you already have a pharmaceutical quality management system but need support in individual subject areas - in terms of content or in terms of documentation - we are ready and prepare:

• Master documents: Site Master File (SMF), Qualification Master Plan (QMP), Validation Master Plan (VMP), Hygiene Master Plan, Pharmacovigilance Master Plan
• Qualification documentation: concept, instructions, templates, plans and reports
  • We set up your qualification system together with you
    • Rooms and clean rooms
    • Monitoring systems
    • Equipment and facilities
    • Supply and media systems
  • We support you in the preparation of qualification documents and in the implementation of the qualification, if required according to your existing system: from the User Requirement Specification (URS) to the technical risk analysis and finally to the release of the qualified premises, facilities or devices.
• Validation documentation: concept, instructions, templates, plans and reports
  • We set up your validation system together with you:
    • Process validation
    • Computer system validation (CSV)
    • Validation of analytical methods
    • Cleaning validation
  • We support you in the preparation of validation documents and in the execution of validation, if required according to your existing system and including formal risk analyses.
• Manufacturing documentation: specifications, batch documentation, certificate of conformity (CoC)
  • We prepare development reports, that map your pharmaceutical development in cooperation with you.
  • We describe your processes with all necessary specifications, instructions (manufacturing instructions, operating instructions, hygiene regulations, etc.) and forms for documentation (e.g. batch record).
• Documentation in quality control: specifications, test instructions and test reports, release certificates (Certificate of Analysis (CoA)
  • We describe your methods with all necessary specifications, instructions (test instructions, operating instructions, hygiene regulations, etc.) and forms for documentation (e.g., test protocol, CoA).
• As well as other SOPs, forms and lists
• We support you in the procurement and implementation of a suitable documentation control system that is suitable for you. There are paper-based, electronic or combined document management systems.
• We offer training services: Not only regarding the contents of a pharmaceutical quality management system, but also in documentation management and Good Documentation Practice.
• We support you in Good Documentation Practice, i.e. in the way your employees document their work: In cooperation with you, we create a concept including instructions for Good Documentation Practice, train your employees and ensure that your forms are suitable and compliant.
• We create concepts to ensure data integrity and support you in their implementation.

All documentation service packages can be requested individually or in combination.

We offer fixed prices for defined overall packages and charge upon proof for continuous project support. Our documentation experts will be glad to advise you in advance of the project, but will of course also support you in the ongoing process.

You can rely on us! We will efficiently implement the demanding requirements of extensive GMP documentation at your site!

Contact us now and benefit from our flexible documentation team that creates GMP documents of all categories quickly & efficiently. Let us know what you need and we will provide you with a quote in a timely manner.